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NDIs: Like it or not, it’s time to lawyer up

Aug 04, 2011

A good football coach tries to put players in roles where they can succeed. He doesn’t ask a player to do something they’re not good at. A good CEO should do the same, and that includes looking at his or her own strengths or weaknesses. If you’re not good at paperwork like regulatory submissions, get help.

The database that the American Herbal Products Association has compiled on the New Dietary Ingredient notifications that have been filed so far contains a wealth of information. One of the things that stands out is the shoddy nature of some submissions. Some documents are so perfunctory that they wouldn’t convince your landlord that the check is in the mail, much less reassure the Food and Drug Administration on consumer safety.

And however the back-and-forth between industry and FDA goes on the subject of the recently released NDI draft guidance, one thing is clear: Many more notifications will need to be filed, so companies will need to up their regulatory game.

“It’s not just in this industry,” said Ivan Wasserman, an attorney with the firm Manatt, Phelps & Phillips who consults with natural products companies on regulatory compliance. “I also do 510(k)s (regulatory submissions to FDA for premarket approval of medical devices). A lot of these companies are more marketers than anything and they don’t know how to speak regulatory speak or to put a regulatory submission together.”

Another recent development that sheds light on this common failing is the news that the European Health and Safety Authority has finished its work on evaluating the thousands of health claims that it has been wading through for years. In many ingredient and food categories the rejection rate for these health claims has been dramtically higher than FDA’s rate of objections on NDI filings. But many of the reasons EFSA cited for its rejections sound familiar notes, namely a lack of precision in identifying the substance for which the company wants to make a health claim, a lack of precision in delineating the claim (such as trying to make a general “vitality” claim) or trying to make a claim on a category that EFSA considers to be overbroad, such as “fruits and vegetables.”

It helps to think like a lawyer when putting these documents together, and that’s why the services of lawyers, even at $300-something an hour, can be seen as cost effective. To say exactly what you mean in a filing without any gray areas that can be interpreted multiple ways is a specialized skill. It seems penny wise and pound foolish to spend tens of thousands of dollars on the science supporting the safety (and efficacy) of a product, and then run into a regulatory ditch with a poorly prepared filing.